(Valerian) for Improving Sleep in Patients With Cancer Receiving Adjuvant Therapy

December 2, 2016 updated by: Alliance for Clinical Trials in Oncology

The Use Of Valeriana Officinalis (Valerian) In Improving Sleep In Patients Who Are Undergoing Adjuvant Treatment For Cancer" A Phase III Randomized, Placebo-Controlled, Double-Blind Study

RATIONALE: The herb Valeriana officinalis (valerian) may promote sleep. It is not yet known whether valerian is effective in improving sleep in patients who are receiving adjuvant therapy for cancer.

PURPOSE: This randomized phase III trial is studying how well valerian improves the quality of sleep in patients who are receiving adjuvant therapy (radiation therapy, chemotherapy, or hormone therapy) for cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the effect of Valeriana officinalis (Valerian) for improving the quality of sleep in patients with cancer receiving adjuvant therapy.

Secondary

  • Determine the safety of this therapy, in terms of frequency and severity of adverse events, in these patients.
  • Determine the effect of this therapy on the degree of anxiety, fatigue, and activities of daily living in these patients.

OUTLINE: This is a double-blind, placebo-controlled, randomized, multicenter study. Patients are stratified according to type of adjuvant treatment (radiotherapy vs parenteral chemotherapy vs oral therapy vs combined modality), age (40 and under vs 41 to 55 vs 56 to 70 vs over 70), and numerical analogue scale for sleep difficulty (mildly impaired sleep quality [4-7] vs moderate or severely impaired sleep quality [8-10]). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral Valeriana officinalis (Valerian) once daily for 8 weeks.
  • Arm II: Patients receive an oral placebo once daily for 8 weeks. After 8 weeks of treatment, patients in arm I may receive Valeriana officinalis (Valerian) for an additional 8 weeks and patients in arm II may cross over to arm I.

Pittsburgh Sleep Quality Index, functional outcomes of sleep, brief fatigue inventory, and profile of mood states questionnaires are completed at baseline and then at weeks 4, 8, 12, and 16.

After completion of study treatment, patients are followed weekly for 2 weeks.

PROJECTED ACCRUAL: A total of 220 patients (110 per treatment arm) will be accrued for this study within approximately 11-22 months.

Study Type

Interventional

Enrollment (Actual)

227

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Aurora Presbyterian Hospital
      • Boulder, Colorado, United States, 80301-9019
        • Boulder Community Hospital
      • Colorado Springs, Colorado, United States, 80933
        • Penrose Cancer Center at Penrose Hospital
      • Denver, Colorado, United States, 80210
        • Porter Adventist Hospital
      • Denver, Colorado, United States, 80220
        • Rose Medical Center
      • Denver, Colorado, United States, 80218
        • Presbyterian - St. Luke's Medical Center
      • Denver, Colorado, United States, 80218
        • St. Joseph Hospital
      • Denver, Colorado, United States, 80224-2522
        • CCOP - Colorado Cancer Research Program
      • Englewood, Colorado, United States, 80110
        • Swedish Medical Center
      • Lone Tree, Colorado, United States, 80124
        • Sky Ridge Medical Center
      • Longmont, Colorado, United States, 80502
        • Hope Cancer Care Center at Longmont United Hospital
      • Pueblo, Colorado, United States, 81004
        • St. Mary - Corwin Regional Medical Center
      • Thornton, Colorado, United States, 80229
        • North Suburban Medical Center
    • Iowa
      • Mason City, Iowa, United States, 50401
        • Mercy Cancer Center at Mercy Medical Center - North Iowa
      • Sioux City, Iowa, United States, 51101
        • Siouxland Hematology-Oncology Associates, LLP
      • Sioux City, Iowa, United States, 51104
        • St. Luke's Regional Medical Center
    • Kansas
      • Wichita, Kansas, United States, 67214
        • CCOP - Wichita
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy and Unity Cancer Center at Mercy Hospital
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, United States, 55432
        • Mercy and Unity Cancer Center at Unity Hospital
      • Hutchinson, Minnesota, United States, 55350
        • Hutchinson Area Health Care
      • Lichfield, Minnesota, United States, 55355
        • Meeker County Memorial Hospital
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology, PA - Maplewood
      • Maplewood, Minnesota, United States, 55109
        • HealthEast Cancer Care at St. John's Hospital
      • Minneapolis, Minnesota, United States, 55407
        • Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center - Minneapolis
      • Saint Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
      • Shakopee, Minnesota, United States, 55379
        • St. Francis Cancer Center at St. Francis Medical Center
      • St Paul, Minnesota, United States, 55102
        • HealthEast Cancer Care at St. Joseph's Hospital
      • St. Paul, Minnesota, United States, 55102
        • United Hospital
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology, PA - Woodbury
      • Woodbury, Minnesota, United States, 55125
        • HealthEast Cancer Care at Woodwinds Health Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of cancer

  • Receiving adjuvant therapy, including any of the following:

    • Radiotherapy
    • Parenteral chemotherapy
    • Oral drugs
    • Hormonal therapy
  • Previously resected tumor, microscopic disease, or nodal or margin involvement allowed
  • Patients receiving intended curative treatment without future planned surgery (i.e., prostate cancer patients receiving radiotherapy followed by hormonal therapy) are eligible

  • Reports difficulty sleeping and seeking therapeutic intervention

    • Defined as a score over 3 on the numerical analogue scale
  • No obstructive sleep apnea
  • No prior diagnosis of primary insomnia per DSM IV criteria

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • At least 6 months

Hepatic

  • SGOT ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 1.5 times ULN

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No chronic symptom that consistently interrupts sleep (e.g., hot flashes, unmanaged pain, or diarrhea)

PRIOR CONCURRENT THERAPY:

Other

  • No prior Valeriana officinalis (Valerian) for sleep
  • More than 1 month since other prior prescription sleeping-aid medication
  • No concurrent benzodiazepines except as short-term treatment for nausea

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
Patients receive oral Valeriana officinalis (Valerian) once daily for 8 weeks.
Dietary supplement: Valeriana officinalis extract
Given orally
Placebo Comparator: Arm II
Patients receive an oral placebo once daily for 8 weeks.
Other: placebo
Given orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Insomnia occurrence by Pittsburg Sleep Inventory at 6 weeks
Time Frame: at 6 weeks
at 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity by questionnaires weekly and CTC grading every 2 weeks
Time Frame: Up to 2 weeks post-treatment
Up to 2 weeks post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

January 9, 2004

First Submitted That Met QC Criteria

January 12, 2004

First Posted (Estimate)

January 13, 2004

Study Record Updates

Last Update Posted (Estimate)

December 6, 2016

Last Update Submitted That Met QC Criteria

December 2, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCTG-N01C5
  • NCI-2011-01604 (Registry Identifier: CTRP (Clinical Trials Reporting System))
  • CDR0000349424 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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